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Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

This study has been terminated.
(This study was terminated early in April 2005 due to low patient enrollment)
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 31, 2005
Last updated: April 19, 2012
Last verified: April 2012
This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.

Condition Intervention Phase
Diabetic Gastropathy
Drug: Tegaserod
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.

Secondary Outcome Measures:
  • Weekly global measure of dyspeptic symptom relief.
  • Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).

Estimated Enrollment: 120
Study Start Date: May 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
  • GI symptoms for at least 2 months before entering study

Exclusion Criteria:

  • Very high body weight
  • Significant diarrhea
  • Ulcers

Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.

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Please refer to this study by its identifier: NCT00142974

Basel, Switzerland, 4056
Sponsors and Collaborators
Study Chair: Novartis Basel
  More Information

Responsible Party: Novartis Identifier: NCT00142974     History of Changes
Other Study ID Numbers: CHTF919G2203
Study First Received: August 31, 2005
Last Updated: April 19, 2012

Keywords provided by Novartis:
Diabetes, tegaserod, gastropathy

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 28, 2017